Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART (NCT07621991) | Clinical Trial Compass
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Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART
India484 participantsStarted 2026-06-01
Plain-language summary
The goal of this prospective observational study is to learn about the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic sperm injection (ICSI). The main questions it aims to answer are:
* Can clinically relevant threshold values of dsSDF and global SDF predict live birth rates following ICSI?
* Does elevated dsSDF reduce live birth rates following ICSI? Participants undergoing ICSI as part of their routine fertility treatment will provide semen samples for global SDF and dsSDF assessment using the R10 Plus and R11 Plus kits, respectively, analysed using the LensHooke® X12 platform before and after sperm preparation. SDF and dsSDF assessments will be performed both prior to and following sperm washing for each participant. Embryos will be assessed from fertilization through embryo development, and following embryo transfer, participants will be prospectively followed for clinical outcomes ranging from biochemical pregnancy to live birth.
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males aged 21-55 years undergoing ICSI treatment for male factor infertility.
* Women with age 21-35 for self-oocyte pickup cycles
* Oocyte donor cycles with recipient age of 21-35 years of age
* Sperm with a minimum total motile sperm count of 2.0 million/mL and a minimum volume of 1.2 mL
* Patients not underwent sperm DNA fragmentation testing
* 2-3 days of abstinence prior to intracytoplasmic sperm injection (ICSI).
Exclusion Criteria:
* Severe male factor infertility (azoospermia or severe oligozoospermia; for this study defined as no sperm present or sample with \<2 million/ml sperm count)
* Known systemic diseases (e.g., diabetes mellitus).
* Surgically retrieved sperms using testicular sperm aspiration, testicular sperm extraction and percutaneous epididymal sperm aspiration.
* Untreated endometrial or uterine factors or adnexal pathology
* Embryos underwent preimplantation genetic testing for aneuploidy testing.
* Patients with thin endometrium (\<7mm)
* Patients opted or underwent donor sperms as the male gamete source.
* Patients underwent antioxidant treatment in last 6 months prior to ICSI treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.